Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients
Launched by YONSEI UNIVERSITY · Jan 9, 2018
Trial Information
Current as of July 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial, titled "Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients," is studying how often patients develop a type of heart rhythm problem called atrial fibrillation (AF), flutter, or tachycardia after getting a pacemaker. The research will involve patients who have had a pacemaker put in and are experiencing these heart rhythm issues. Over a period of five years, the study will compare the recurrence rates of these heart problems in two different groups of patients to understand the long-term effects of pacemakers.
To be eligible for this trial, participants need to be between the ages of 18 and 80 and must have developed AF, flutter, or tachycardia after their pacemaker implantation. They should also be able to safely receive a pacemaker according to specific guidelines. Participants will need to sign a consent form and commit to follow-up appointments after the surgery. It’s important to note that individuals with certain health conditions, like severe liver or kidney issues, or those who are pregnant, won't be able to participate. If you or a loved one is considering joining this study, you can expect regular check-ups and monitoring over the next five years to help improve our understanding of pacemakers and heart rhythm problems.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872).
- • Age: 18-80 years
- • Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation
- • Estimated percentage of atrial pacing \>40% under sinus rhythm (LR≥60bpm, close hysteresis and rest rate)
- • Estimated percentage of ventricular pacing \>40% under sinus rhythm (LR≥40bpm, DDD pacing, close hysteresis and rest rate)
- • Patients who are willing to sign the informed consent.
- • Patients who are willing to receive the implantation and post-operative follow-up.
- Exclusion Criteria:
- • Persistent or permanent AF
- • Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr \> 3.5 mg/dl or Ccr \< 30ml/min)
- • Thyroid gland dysfunction
- • Pregnancy
- • Malignant tumor
- • Severe organic heart disease (such as moderate to severe mitral regurgitation, severe valvular regurgitation and stenosis, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)
- • Life expectancy \< 12 months
- • Patients unable or unwilling to cooperate in the study procedures.
About Yonsei University
Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, , Korea, Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials